Monday, August 25, 2008

Exploring The New CBE Rule

We've now had a chance to review the new "change being effected" (or "CBE") rule finalized by the FDA last week. (Here's a link.) Here are the cites: 73 FR 49603, 2008 WL 3874230. For drugs, the rule is 21 C.F.R. Sec. 314.70(c)(6).

This is what we found.

First, the FDA made one change from the draft rule that it proposed in January to the final rule that it adopted last week. The draft rule said that "newly acquired information" included data "derived from new clinical studies, reports of adverse events of a different type or greater severity or frequency than previously included in submissions to FDA, or new analyses of previously submitted data."

The final rule changes the location of the italicized words. In the final rule, "newly acquired information" includes data "derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA."

This change clarifies that the (what the heck is that? an adjectival phrase?) applies to all of the types of data, rather than just the adverse event reports.

We found some stuff we like in the FDA's responses to the comments submitted about the draft rule. At page 6, you'll see the FDA's statement that, "A sponsor's submission or FDA's acceptance of a CBE supplement does not necessarily mean that a drug product actually has caused any particular adverse event or type of adverse event." That should go without saying, but we're glad to see it said nonetheless.

One commenter suggested that the FDA should distinguish situations in which a drug company "must" warn of a risk from situations in which a sponsor "may" warn. The FDA rejected that suggestion because the FDA-approved warning on a drug is both a floor and a ceiling on the risk information that should be provided: "FDA has previously stated and reiterates here that it 'interprets the Act to establish both a 'floor' and a 'ceiling', such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise misleading.'" Id. at 7.

As the FDA (and the Supreme Court) has said before, "FDA does not believe that the absence of an express preemption provision with respect to drugs affects the application of the doctrine of implied preemption." Id. at 8.

The FDA devotes a couple of paragraphs to explaining the "rule of construction" found in the recently enacted Food and Drug Administration Amendments Act of 2007. Among other things, "the rule of construction operates to preserve Federal labeling obligations only in the face of an argument that 'this paragraph' . . . 'affects' [the drug manufacturer's] responsibilities." Since the rule of construction is limited to that one paragraph, it cannot be read to apply to the FDAAA (or the FDCA) as a whole.

The FDA rejected one comment's proposal that the agency "provide a comprehensive, written response to every CBE supplement submitted to the agency by a sponsor, describing FDA's ground for approval, disapproval, or, as the case may be, request for modification to the submitted CBE supplement." Id. at 18. The FDA's position may disappoint those who favor Catherine Sharkey's "agency deference" model of preemption, but it does save the agency a lot of work.

Finally, the FDA repeats that the new CBE rule simply codifies what had been the agency's longstanding CBE practice (id. at 22) and repeats the FDA's now oft-stated views on preemption. Id. at 23. And, in a sentence that may occasionally prove useful in litigation, the FDA writes that "at least when a sponsor did not meet the standard to change its labeling through a CBE supplement under this rule to include the warning a plaintiff alleges should have been added to labeling, State law liability that is premised on a failure to warn is preempted." Id. at 24.

3 comments:

What the heck does this sentence mean? "And, in a sentence that may occasionally prove useful in litigation, the FDA writes that "at least when a sponsor did not meet the standard to change its labeling through a CBE supplement under this rule to include the warning a plaintiff alleges should have been added to labeling, State law liability that is premised on a failure to warn is preempted."

Does it mean that even if a sponsor doesn't meet the standard to change its labeling, state law is still pre-empted by FDA approval?

I believe this is important to the bloggers in regard to situations like the SSRI suicide warnings where the FDA looked at the evidence numerous times and rejected the language at issue. The particular regulation would pre-empt state law claims of that nature.

In the sentence Fables quotes, the FDA is addressing a situation where the sponsor's data does not meet the standard for "new" scientific evidence that the CBE regulation now explicitly imposes. Thus it's discussing data that does not satisfy the threshhold for making a CBE change. The FDA is not referring to a situation where the manufacturer could have successfully submitted a CBE label change under the regulation, but did not do so.

About

This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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